INSTRUCTIONS FOR OBTAINING AND DOCUMENTING INFORMED CONSENT OF
SUBJECTS WHO DO NOT SPEAK ENGLISH
The Department of Health and Human Service regulations for the protection of human
subjects requires that informed consent information be presented "in language
understandable to the subject" and, in most situations, that informed consent be
documented in writing.
Where informed consent is documented, the written consent document should embody,
in language understandable to the subject, all the elements necessary for legally
effective informed consent. Subjects who do not speak English should be presented with
a consent document written in a language understandable to them. The Office for
Human Research Protection strongly encourages the use of this procedure whenever
possible.
Alternatively, oral presentation (in the subjects’ native language) of the IRB approved
informed consent document in conjunction with a short form written in a language
understandable to the subject can be used. When this procedure is used, a translator
(could be a family member who is fluent in both English and the language of the subject)
will read the IRB approved informed consent document to the subject and the subject
will read the short form which is written in a language understandable to him/her.
SIGNATURES:
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At the time of consent, the short form document is signed by the subject
The English language informed consent document is signed by the person
obtaining consent as authorized under the protocol (research nurse/assistant or
PI)
Both the short form document and the English language informed consent
document must be signed by the translator (could be family member who is fluent
in both English and the language of the subject).
The subject must be given copies of the short form document and the English version of
the IRB approved informed consent document.
It is the responsibility of the IRB to determine which of the procedures above is
appropriate for documenting informed consent in protocols that it reviews.